RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.

The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.

About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

European Regulatory Roundup: UK to Increase Regulatory Oversight of Antibiotics (22 September 2016)

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

UK Government Plans Significant Increase in Regulatory Oversight of Antibiotics

The United Kingdom government expects regulatory oversight of veterinary antibiotics to increase significantly in the future. Ministers singled out the enactment of legislation that restricts or bans the veterinary use of antibiotics that are of critical importance to people as one of the ways they foresee the regulatory landscape changing.

Jeremy Hunt and Andrea Leadsom, the politicians in charge of health and the environment in Britain, made the comments in a report published in response to Jim O’Neill’s government-commissioned Review on Antimicrobial Resistance. The government response, in keeping with O’Neill’s review, is a wide-reaching text that covers many topics beyond the control of British politicians or any regulator, but some of the comments directly address how the Medicines and Healthcare Products Regulatory (MHRA) should approach antimicrobial resistance and interact with its peers around the world.

The aforementioned restrictions and bans on the use of certain antibiotics in animals is an area in which the British government wants to see global action. Specifically, the ministers call for the World Health Organization, Food and Agriculture Organization and World Organisation for Animal Health to agree on a single, harmonized list of restricted or banned antibiotics “as a matter of urgency.” The British government intends to encourage the creation of a list through its environment department and, in a reflection of the diplomatic aspects of the task, its foreign office.

Some of the government recommendations will necessitate a mix of local and international actions. On the topic of discharge from antimicrobial active pharmaceutical ingredient (API) manufacturing plants, for example, the government will “encourage” firms “to limit environmental contamination” voluntarily. In parallel, ministers want to work with the General Assembly of the United Nations and the European Commission on the more hardline plan of establishing “evidence-based, enforceable targets for maximum levels of antimicrobial API discharge.”

The desire to collaborate with the rest of the European Union raises the question of what happens if, as expected, Britain goes ahead with Brexit. Hunt and Leadsom address the question in vague terms in the report, noting the United Kingdom remains a full member of the EU and what happens after it leaves will only become clear once exit negotiations are concluded. For now, ties to the EU are vital to the antimicrobial resistance strategy — “Europe” and “European” are used in the report almost as often as “MHRA” — but this may well change, particularly if Leadsom influences the process.

When Leadsom, who positioned herself as the most anti-EU politician in the Conservative leadership race, took up the position of environment minister, she published a blog post stating leaving the EU would “reduce burdensome EU red-tape, saving farmers time and making food cheaper.”

The European Medicines Agency (EMA) has ruled there is no need for additional, Zika virus-focused safety measures for plasma and urine-derived products. EMA looked into the topic amid concerns products manufactured from body fluids could pose a threat to patients in Europe, but found the Zika virus is inactivated or removed during the production processes.

Officials at EMA tasked the Committee for Medicinal Products for Human Use (CHMP) with assessing the risks posed by plasma-derived products, and put the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) in charge of coordinating member states’ reviews of the safety of urine-derived products. In summarizing the findings, the Biologics Working Party (BWP) said no additional safety measures are needed for either plasma-derived or urine-derived products, a stance underpinned by confidence in the production processes.

With regard to plasma-derived products, the requirement to perform steps such as solvent-detergent treatment, pasteurization and virus filtration during production is expected to remove or inactivate any Zika that is present in the starting materials. In light of the track record of these manufacturing processes yielding safe plasma-derived products, BWP concludes there is no need to test donors for Zika virus RNA. The decision is in line with that reached by the United States Food and Drug Administration last month.

BWP is similarly confident in the production process used for urine-derived products. Zika virus RNA has been found in urine, and there is a possibility the load will be higher than is present in blood. As such, manufacturers were asked to assess the risks posed by their products. The product-specific risk assessments led BWP to conclude the use of nanofiltration and pasteurization is sufficient to eliminate Zika virus. Even so, manufacturers have taken the precautionary step of stopping sourcing urine from Brazil.

The European Commission has released a roadmap detailing ways to strengthen cooperation on health technology assessments (HTAs). Officials have proposed five paths forward, ranging from the continuation of the current system to cooperation on the production of complete joint HTA reports.

Under pressure from the pharmaceutical industry, member states have begun to look into ways they can eliminate some of duplicated efforts and divergent approaches that characterize HTAs in Europe today. These early moves toward harmonization have fallen short of what some drug developers, patient groups and member states want. Yet, with other countries keen to keep control of their national HTA processes, there is also resistance to complete convergence.

Faced with these factions, the commission has suggested a handful of ways to proceed. At one end of the spectrum is the continuation of the current practice of joint actions. However, with funding for the scheme due to end in 2020, the commission is skeptical about whether this approach can achieve the overarching goal of reducing the duplication of methodologies and procedures. For drug developers facing different HTA processes across the EU, this is a pressing concern.

At the opposite end of the spectrum, the commission is proposing joint production of HTA reports that assess the clinical and economic merits of a medicine. In this scenario, uptake of the HTA reports by member states would be mandatory. This would significantly cut the duplication of HTA efforts but would require permanent funding from the EU and the industry. The approach may prove unpopular with some member states, something the commission acknowledges in its roadmap.

The commission has proposed several options between these extremes and offered its take on what would be required to enact them and how they would advance the HTA cooperation agenda. Which of these options prevails will depend to a large extent on the ability of the drug developers and other organizations in favor of harmonization to persuade skeptical member states that their interests are best served by eliminating duplication.

EMA is asking marketing authorization applicants for feedback on its evaluation procedure. The survey will cover the whole process, from pre-submission through to opinion finalization. EMA is also polling its own staff and rapporteurs about their experience of the approval process. The plan is to share the findings in the second quarter of 2017. EMA Notice

The Paediatric Committee (PDCO) at EMA has re-elected Dr Dirk Mentzer for a second three-year term. PDCO is primarily involved in assessing and ruling on pediatric investigation plans. EMA Notice